In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus; Childhood Obesity; Pediatric Obesity; Glucose Metabolism Disorders; Overnutrition; Overweight; Body Weight; Behavior, Adolescent; Metabolic Disease
• Interventions: Behavioral: Black Girls for Wellness In-Person

• Registration Number: NCT06557317
• Lead Sponsor: Cornell University

Brief Summary

The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week in-person lifestyle program.

Detailed Description

Enrolled adolescent/caregiver dyads will participate in the 12-week program. Each week, participants will engage in 2 activities: an in-person Wellness Session and an at-home cooking experience using ingredients provided at the Wellness Session.

The study will examine the pre-post difference in overall diet quality, dermal carotenoid levels, physical activity, body composition, and glycemic measures among at-risk black adolescent girls and their caregivers. Investigators hypothesize that after the program, participants' diets will be higher in quality than before.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Adolescent/Caregiver Dyads	Black Girls for Wellness In-Person	Adolescent/Caregiver dyads receive 12-week in-person lifestyle program consisting of a Wellness session, Dance Classes, and an at-home Cooking Experience.

Primary Outcome Measures

Name	Time	Method
Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores	Baseline, 12 weeks [end of study]	Scores are calculated from three 24-hour diet records, range from 0-100. Higher score reflects that higher alignment between one's diet and dietary recommendations from the Dietary Guidelines for Americans.

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	Baseline, 12 weeks [end of study]	HbA1c will be assessed through a blood draw.
Change in dermal carotenoids level	Baseline, 12 weeks [end of study]	Scores are measured using the Veggie Meter device, range from 0-800. Higher score acts as proxy for fruits and vegetables consumption.
Change in percent time sedentary	Baseline, 12 weeks [end of study]	Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent on sedentary will be calculated.
Change in percent time spent in light activity	Baseline, 12 weeks [end of study]	Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in light activity will be calculated.
Change in percent time spent in moderate to vigorous activity	Baseline, 12 weeks [end of study]	Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in moderate and vigorous activity will be calculated.
Change in body mass index	Baseline, 12 weeks [end of study]	Height will be measured using a stadiometer to the nearest decimal point in cm. Weight will be measured using a scale to the nearest decimal in kg. Body mass index will be calculated using kg/m\^2.
Change in high blood pressure status	Baseline, 12 weeks [end of study]	Blood pressure will be measured using blood pressure monitors. High blood pressure is considered as reading of \>=120/80.
Change in lipid profile	Baseline, 12 weeks [end of study]	Total, high-density, low-density cholesterol, and triglycerides will be assessed through a blood draws.
Change in body fat percentage	Baseline, 12 weeks [end of study]	Body fat percentage will be measured using a scale to the nearest decimal.
Change in waist circumference	Baseline, 12 weeks [end of study]	Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.

Trial Locations

Locations (1)

Brownsville Neighborhood Health Action Center; 🇺🇸 Brooklyn, New York, United States